To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
Completed · Phase 1
Conditions studied: Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
In brief
A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations of diacerein and rhein.
Key facts
- Study ID
- NCT03472287
- Run by
- Castle Creek Pharmaceuticals, LLC
- People needed
- 11
- Starts
- 2018-05-18
- Expected to finish
- 2019-02-14
- Last updated by the study team
- 2020-02-10
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford School of Medicine — Palo Alto, California, United States
- Northwestern University Medical Center — Chicago, Illinois, United States
- UNC Dermatology — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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